Sioux Falls Specialty Hospital

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 46511 18559 50715 Based on observation, record review, interview, and policy review, the provider failed to: *Maintain appropriate temperatures in 15 of 15 operating rooms (OR) within acceptable standards of practice. *Accurately monitor patient’s temperatures in the OR to prevent possible hypothermia (low body temperature) and other related complications for 22 of 33 sampled patients (1, 2, 3, 4, 5, 6, 7, 9, 10, 12, 14, 15, 16, 18, 19, 23, 24, 26, 27, 28, 31, and 32). *Ensure 4 of 33 sampled patients (9, 14, 15, and 31) maintained a skin temperature greater than 90 degrees F during their surgical procedure. *Ensure OR temperatures were within acceptable standards of practice during 31 of 33 sampled patient’s procedures (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33). Findings include: 1. Observation on 7/15/24 at 2:09 p.m. in OR #11 revealed the room’s digital thermometer temperature reading was 64.4 degrees Fahrenheit (F). Review of the provider’s temperature and humidity log from, 3/1/24 through 7/15/24 of all 15 OR’s revealed the temperatures were documented to be less than 68 degrees F. Observation on 7/16/24 at 9:05 a.m. in OR #11 for patient 13’s procedure revealed, the recorded temperature was 64.2 degrees F. Observation on 7/16/24 at 9:21 a.m. in OR #16 for patient 12’s procedures revealed, the recorded temperature was 65 degrees F. Review of the 33 sampled patients’ charts related to OR temperatures during their procedures revealed: *Thirty-one patients’ procedures were performed outside the acceptable standards of practice for OR temperatures of 68-73 degrees F. -Those temperature ranges had been 62 degrees F to 67 degrees F. *Twenty-two patients had a documented skin temperature during their surgical procedure had fallen below 95.9 degrees F. *Four patients had a documented skin temperature in the 80’s during their surgical procedure. The OR temperatures were: -64 degrees F for patient 9. -65 degrees F for patient 14. -66 degrees F for patient 15. -65 degrees F for patient 31. Interview on 7/17/24 at 1:10 p.m. with chief nursing officer (CNO) K revealed: *She worked with the Accreditation Commission for Health Care (ACHC) on temperatures in the OR. *The ACHC recommended performing a risk assessment. *The provider changed their OR parameters for temperatures based on evidence. *She worked with the previous director of plant operations but he is no longer with them. -She was unable to determine the reference or resource used to score the risk assessment. *The provider had based their decision on low surgical site infection rates for them. *The provider had chosen the temperature ranges based on the temperatures the OR rooms were running. *She stated,”Surgeons drive the practice and temperatures are set based on their preference.” *They had not seen any patient complications, but there was the potential. Interview on 7/17/2024 at 1:25 p.m. with medical director U revealed: *Patient’s temperatures of 95.9 degrees F to 98.6 degrees F would have been generally within the accepted range. *If patient’s temperatures were outside the accepted range, they would have provided an intervention. *Patient’s temperatures outside the accepted range can lead to an increase in complications such as: -Infection. -Coagulation (blood clotting) issues. -Blood sugar control. -Longer hospital stays. *Skin temperatures were taken with a probe in the armpit or any area on the skin that would have given an accurate reading. *Skin temperatures provides a trend to determine treatment. *A negative trend would have been a patient’s temperatures changing more rapidly. *They would have been more concerned more with a downward trend than an upward trend. *If temperatures are trending down, they would have wanted to get a more accurate measurement of their temperature by obtaining a core temperature or using a different type of thermometer. Interview on 7/17/24 at 1:44 p.m. with chief certified registered nurse anesthetist (CRNA) C revealed: *Ideal core (temperature of the body’s internal organs) temperatures range had been 96.8 degrees F to 100.4 degrees F. *Skin temperatures ran lower than a core temperature. *The provider performed both core and skin temperatures. *Temperatures could have varied depending on where you had measured on the body. *When a patient’s temperature had been trending down, other interventions should have been carried out. Such as: -Forced air warming. -Heated intravenous fluids. *The standard of practice was to warm the patient in the pre-operative area first. *If interventions had been unsuccessful, the anesthesiologist would have been notified. *The patient temperatures that had been documented in the 80’s was not normal. *There would have been a need for accurate documentation of how temperatures were obtained. *”The OR temperatures were too cold and have always been a topic of discussion.” Review of the provider’s undated Temperature and Humidity in the OR policy revealed: *Purpose of the policy is to maintain OR temperatures in accordance with recommended standards, the interest of the patient, and environmental safety. *Resources for the policy are: -Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, 2019 edition. -American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 170-2008. -Association for the Professional in Infection Control and Epidemiology (APIC) text, 4th Edition. *”Temperature ranges are established by performing an annual life safety risk assessment.” *The temperature range for the OR is 60 degrees F-72 degrees F. *Patient temperatures will be monitored in the OR to maintain normothermia and ensure patient safety. Review of the provider’s undated risk assessment for OR temperature parameters revealed: *Temperature range assessed was for 60 degrees F to 67 degrees F in the OR. *Risk to patient is low. *Risk to team member is none. *Risk to facility is none. *Risk to surgeon is none. *Financial risk is none. *Overall risk level is low. *Risk assessment had no documented date of approval. *No documentation or evidence was listed to support the provider’s findings or conclusions. Review of AORN 2020 edition, pg. 329 revealed hypothermia happens when body temperature is less than 96.8 degrees F. Review of ASHRAE Standard 170-2008 for operating room temperature range is 68-75 degrees F. Review of APIC text, 4th edition design standards for operating rooms recommended a temperature of 68 degrees F to 75 degrees F. Review of the Administrative Rules of South Dakota 44:75:13:23 ventilating systems revealed: *”A facility shall ensure its ventilating systems maintain temperatures, minimum air changes of outdoor air per hour, minimum total air changes, and relative humidities as follows: -For operating rooms, sixty-eight to seventy-three degrees Fahrenheit or twenty to 22.8 degrees centigrade, three outdoor, twenty total, and twenty to sixty percent humidity.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 50715 Based on observation, interview, and policy review, the provider failed to ensure: *Expired medications in two of two anesthesia carts were not available for patient use. *Multi-dose vials of medications were dated with a 28-day expiration date from the date of opening. *Single dose vials of medications were not reused or made available for multiple patients. Findings include: 1. Observation on 7/16/24 at 10:00 a.m. of (OR) #14’s anesthesia cart revealed: *An opened multi-dose vial dexamethasone (medication for nausea and vomiting) was not labeled with a 28-day expiration date. *An opened multi-dose vial rocuronium (muscle relaxant) 50 mg was not labeled with a 28-day expiration date. *An opened single-dose vial dexamethasone was available for patient use. *An opened single-dose vial phenylephrine (medication for low blood pressure) was available for patient use. *A vial of Xylocaine (numbing medication) 50 milliliters (ml) was outdated on 5/2024. *An unlabeled 20 ml syringe filled with a white liquid was in drawer and ready for patient use. -The medication was identified as propofol (sedative). Interview on 7/16/24 at 10:10 a.m. with certified registered nurse anesthetist (CRNA) A revealed: *She had not used any of the opened single dose vials left in the drawer. *Used single-dose vials should have been thrown out prior to the next patient. *Multi-dose vials are good for 28 days from the date it was opened. *Multi-dose vials are dated with the open date and the medication would have expired 28 days from the open date. *Multi-dose vials should be discarded and not used if vials are open with no date. *Propofol should be labeled with the drug, concentration, and expiration date/time. 2. Observation on 7/16/24 at 10:30 a.m. of OR #4’s anesthesia cart revealed: *An opened multi-dose vial lidocaine (numbing medication) 500 milligrams (mg) not labeled with a 28-day expiration date. *A multi-dose vial 0.5% lidocaine 250 mg had expired February 2024. *A multi-dose vial of labetalol (lowers blood pressure) 100 mg labeled with an open date of 6/5/2024. *An opened multi-dose vial dexamethasone was not labeled with a 28-day expiration date. Interview on 7/15/24 at 10:35 a.m. with CRNA B revealed: *Expired medications should not have been used for patients. *Multi-dose vials were good for 28 days from the date it was opened. *Multi-dose vials should be discarded and not used if vials are open with no date. *Labetalol 100 mg multi-dose vial should have been discarded on 7/3/2024. 3. Interview on 7/16/24 at 2:22 p.m. with chief CRNA C revealed: *The anesthesia department was responsible for performing monthly checks for expired medications and supplies. *Anesthesia technicians assisted with these checks. *CRNA’s have overall accountability to check for outdated medications. *Multi-dose vials should have been labeled with a 28-day expiration date from the date opened or discarded after use. *An opened multi-dose vial not dated with a 28-day expiration date should be discarded and not used for patients. *Opened single dose vials should have been discarded after drawn up and not placed back into the anesthesia cart. *Single dose vials are used for one-time use. 4. Review of the provider’s undated Medication Administration and Disposal policy revealed the provider should have: *Labeled medications transferred from original container to new container, with the medication name, strength/concentration, and amount. *Verified the medication had not expired. *Labeled unopened multi-dose vials with an expiration date that was 28 days from the opening date.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 50715 Based on observation, interview, and policy review, the provider failed to ensure five of five registered nurse (RN) and certified registered nurse (CRNA) staff: *Disinfected the intravenous (IV) port with an alcohol swab for 15 seconds prior to medication administration according to their policy. *Performed hand hygiene after gloves are removed. *Performed hand hygiene when contamination has occurred. *Performed hand hygiene prior to obtaining clean supplies. Findings include: 1. Observation on 7/15/24 at 12:43 p.m. in the Post-Anesthesia Care Unit (PACU) revealed RN D disinfected patient 34’s IV port with an alcohol swab for four seconds prior to the administration of normal saline. 2. Observation on 7/15/24 at 1:22 p.m. during patient 34’s procedure in operating room (OR) #9 of CRNA E revealed she: *Put on a new a pair of gloves. *Disinfected the IV port with an alcohol swab for five seconds prior to the administration of fentanyl (pain medication). *Opened the anesthesia cart and grabbed a vial of medication out of the drawer with the same gloves on her hands. *Removed the gloves, no hand hygiene was performed, and then put on a new pair of gloves. *Removed nursing supplies from anesthesia cart and used on patient. 3. Observation on 7/15/24 at 1:41 p.m. in OR #9 of RN F revealed she: *Put on a new pair of gloves. *Scrubbed patient’s 34’s right shoulder with chlorhexidine (skin disinfectant). *Reached into a clean drawer with other medical supplies to grab another chlorhexidine prep with the same gloves on her hands. 4. Observation on 7/16/24 at 9:05 a.m. in OR #11 of CRNA H with patient 13 revealed she: *Put on gloves to place oxygen in the patient’s nose. *Removed the gloves, opened the anesthesia cart, and removed patient supplies. *Put on a new pair of gloves and grabbed medication from the anesthesia cart. *Removed the gloves, scanned the patient’s arm band, and then performed hand hygiene. *Administered an IV medication without disinfecting the IV port with an alcohol swab. *Performed hand hygiene. *Disinfected the IV port with an alcohol swab for two seconds prior to the administration of IV ancef (antibiotic). 5. Observation on 7/16/24 at 9:21 a.m. in OR #16 of CRNA I with patient 12 revealed he: *Disinfected the IV port with an alcohol swab for five seconds prior to the administration of ancef. *Administered 1000 milligrams (mg) of tranexamic acid without disinfecting the IV port with an alcohol swab. 6. Interview on 7/16/24 at 9:54 a.m. with Certified Surgical Technologist (CST) T revealed: *Hand washing education was completed on a yearly basis. *After gloves have been removed the staff should have washed their hands or used hand sanitizer. 7. Interview on 7/15/24 at 2:50 p.m. with OR RN supervisor G revealed she: *Would have expected alcohol-based hand sanitizer or soap and water to have been used before and after glove use. *Would have expected staff to have clean hands prior to obtaining clean supplies from drawers. *Would have expected staff to clean the IV port with an alcohol swab or a chloraprep (skin disinfectant) for 15-30 seconds prior to medication administration. 8. Interview on 7/16/24 at 2:03 p.m. with infection prevention (IP) employee health RN J revealed: *The staff were expected to wash hands after removing gloves and prior to putting on a new pair. *Staff should have clean hands or gloves prior to obtaining clean supplies. *All staff had received yearly education on hand hygiene practices and policies. *Staff had received education on medication administration. *Prior to accessing the IV port, an alcohol swab should have been used for 15 seconds prior to the administration of medications. 9. Interview on 7/16/24 at 2:22 p.m. with chief CRNA C revealed: *Hand hygiene should have been performed after gloves had been removed. *Hands should have been cleaned prior to getting supplies out of the anesthesia drawers. *Prior to administering IV medications or accessing IV line, the expectation was to use an alcohol swab on the access site for 15 seconds. 10. Interview on 7/17/24 at 3:23 p.m. with chief nursing officer (CNO) K revealed: *”Hand sanitizer machines were placed strategically so patients could see staff use it.” *When gloves are removed, staff should have washed their hands before putting on a new pair of gloves. *The expectation would have been to disinfect the IV port with an alcohol swab for 15 seconds prior to medication administration. 11. Review of the provider’s undated Handwashing policy revealed: *”All staff and personnel having direct patient care will clean hands at a minimum the following times: -Before and after patient contact, including dry skin contact. -After removing gloves. -Before performing invasive procedures. -After handling equipment, supplies, or linen contaminated with body substances. -Before handing sterile or clean supplies.” 12. Review of the provider’s undated Standard Precautions policy revealed: *”Gloves are to be changed after contact with each patient and between procedures on the same patient. *Hand hygiene will occur immediately or as soon as feasible after removal of gloves or other personal protective equipment. Alcohol-based hand sanitizers will be used if water is inaccessible. *Hand hygiene is to be performed before and after each patient contacts, when contamination has occurred and when gloves are removed.” 13. Review of the provider’s undated Intravenous Therapy-Peripheral-Saline Lock policy revealed: *”Medication infusion and/or flushing: -Swab injection site with an alcohol swab for at least 15 seconds and allow area to dry.””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 50715 Based on observation, interview, and policy review, the provider failed to ensure four of four carts holding contaminated instruments containing blood and bodily fluids had been transported in a sealed container and were labeled as biohazardous. Findings include: 1. Observation on 7/15/24 at 2:09 p.m. in operating room (OR) #11 revealed: *Surgical instruments used during the operation had been separated and placed into different containers with no lids on them. *The containers had been placed on a table with wheels for transportation to central processing (department where re-usable instruments are cleaned and repackaged). *The needles and sharp objects had been separated and discarded separately. *All the used instruments were sprayed with a pre-klenz (pre-treatment gel) prior to transporting to central processing. *A large drape had been placed over the instruments in the containers. *The table and instruments were moved out of the OR and rolled to central processing for decontamination and reprocessing. *The drape covering the instruments was not labeled as biohazardous and puncture-resistant. Observation on 7/16/24 at 9:38 a.m. in OR #15 revealed: *Five containers of contaminated instruments consisting of scissors, drills, tweezers, and screwdrivers were on a long table with wheels. *The instruments had been separated and treated with pre-klenz and were not placed in sealed containers. *A large drape was placed over the table and covered the contaminated instruments. *The drape was not labeled as biohazardous. *The table was pushed into the OR corridor and rolled to central processing. Interview on 7/16/24 at 9:45 a.m. with central sterilization room technician S revealed: *Instruments were precleaned in the OR prior to transportation to central processing. *Instruments were separated into containers with needles and other sharps discarded. *She confirmed: -The containers for transporting the used instruments did not have lids. -A biohazardous label was not on the drape. -This had been their process used to transport contaminated instruments. Observation on 7/16/24 at 10:20 a.m. in the OR corridor revealed: *Contaminated instruments had been placed in non-sealed containers on a large table with wheels. *Instruments had been pretreated with pre-klenz. *Instruments had been covered with a large drape. *There was not a biohazardous label on the drape. Interview on 7/16/24 at 10:30 a.m. with OR supervisor registered nurse (RN) G revealed: *”This is our policy on transportation of contaminated items. *Contaminated instruments are sprayed in the OR, separated, placed into containers, and a large drape is placed over the instruments. *We have done it this way for years.” Interview on 7/16/24 at 2:03 p.m. with infection prevention (IP) employee health RN J revealed: *The provider used Association of perioperative Registered Nurses (AORN), Association for Professional in Infection Control and Epidemiology (APIC), and Association for the Advancement of Medical Instrumentation (AAMI) national guidelines to guide their practice and write policies. *Contaminated instruments should have been in a sealed, puncture resistant container, and labeled as biohazard. *”We were told this at one time because this is how we transport our dirty scopes.” Review of the provider’s undated Handling, Care, and Transportation of Contaminated Items policy revealed: *Purpose -“To provide guidelines for OR scrub team members for the careful and safe return of instruments to decontamination area for cleaning and decontamination prior to resterilization.” *Reference AAMI 6.4: -“Prior to leaving the OR, the scrub team members will remove all sharps from instruments and power equipment to be reprocessed and placed in appropriate sharps container. -Disassemble all instruments that have come in direct patient contact by using a separate basin or towel taking care to keep instrument trays together by inventory. -Cover table or place contaminated instruments in a sealed container to transport to decontamination room to prevent spread of pathogens.” Review of AAMI national guidelines ST 79:2017 pg. 36 revealed: *”To help prevent damage to reusable items and avoid contamination of the environment, transport carts or other system should: -Be designed to prevent items from falling over or off during transport. -Be covered or closed. *Prior to transportation, items contaminated with blood and other potentially infectious materials should be placed in a container that is puncture-resistant, leak-proof on the bottom and sides, labeled as biohazardous, and sealed. *Rationale: Materials contaminated with blood or other bodily fluids can serve as a sources of infection to personnel unless the materials are completed contained. Containment minimizes the possibility of airborne or contact spread of microorganisms.””

“Means of Egress - General CFR(s): NFPA 101 Means of Egress - General Aisles, passageways, corridors, exit discharges, exit locations, and accesses are in accordance with Chapter 7, and the means of egress is continuously maintained free of all obstructions to full use in case of emergency, unless modified by 18/19.2.2 through 18/19.2.11. 18.2.1, 19.2.1, 7.1.10.1 This Standard is not met as evidenced by: 18087 Based on observation and interview, the provider failed to maintain a protected path of egress at two randomly observed locations (second floor stairwell one and northwest exit). Findings include: 1. Observation on 7/15/24 at 1:50 p.m. revealed the second floor corridor in front of stairwell one had a Hoyer lift and a portable x-ray machine kept in the corridor at the stairwell door location. The access to the egress door could be reduced by the equipment kept in that location. 2. Observation on 7/15/24 at 3:45 p.m. revealed the egress corridor at the northwest exit one had seven plastic totes measuring 24 inches by 30 inches by 18 inches tall in the path of egress from the ground floor and in the elevator ground floor discharge location. Further observation revealed a sign was posted indicating how to handle items delivered to the building at that location. 3. Interview with the environmental services manager at the time of the observation confirmed that condition. The deficiency had the potential to affect 100% of the smoke compartment occupants.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 18087 Based on observation, testing, and interview, the provider failed to maintain six separate hazardous areas (storage rooms) as required. Findings include: 1. Observation and testing on 7/15/24 at 2:20 p.m. revealed room 309, the soiled utility room corridor door, would not close and latch with the operation of the closer. 2. Observation and testing on 7/15/24 at 3:00 p.m. revealed the 1-1/2 hour fire-rated door to the generator room in the lower level would not close and latch with the operation of the closer. 3. Observation and testing on 7/15/24 at 3:15 p.m. revealed the lower level material storage room (storage room 2) was over 100 square feet in area with a quantity of combustible items. The corridor door was equipped with spring hinges, but the door would not close and latch upon the action of the spring hinges. 4. Observation and testing on 7/15/24 at 3:20 p.m. revealed the lower level hospitality room (storage room 1) was over 100 square feet in area with a quantity of combustible items. The corridor door was equipped with spring hinges, but the door would not close and latch upon the action of the spring hinges. 5. Observation and testing on 7/15/24 at 3:25 p.m. revealed the lower level storage room 3 was over 100 square feet in area with a quantity of combustible items. The corridor door was equipped with spring hinges, but the door would not close and latch upon the action of the spring hinges. 6. Observation and testing on 7/15/24 at 3:30 p.m. revealed the lower level storage room 4 was over 100 square feet in area with a quantity of combustible items. The corridor door was equipped with spring hinges, but the door would not close and latch upon the action of the spring hinges. 7. Interview with the director of plant operations at the times of the observations confirmed those findings. The deficiency affected one of numerous requirements for hazardous storage rooms and had the potential to affect 100% of the occupants of the smoke compartment.”